Effect of Supplemental Vitamin D on Skeletal Muscle Function in Chronic Obstructive Pulmonary Disease (COPD) Patients

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

Effect of Supplemental Vitamin D on Skeletal Muscle Function in COPD Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00914810
• Other study ID #: 4129-A
• Status: Completed
• Phase: Phase 3
• First received: June 4, 2009
• Last updated: June 7, 2013
• Start date: June 2009
• Est. completion date: October 2011

Study information

• Verified date: June 2013
• Source: Minneapolis Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether or not vitamin D supplementation can improve physical performance in persons with severe chronic obstructive pulmonary disease (COPD).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• COPD

• Forced expiratory volume in one second (FEV1) < or = 50% of predicted

• Smoking history of at least 10 pack-years

• Able to ambulate independently or with the use of an ambulatory assist device (such as a cane or walker)

Exclusion Criteria:

• Currently taking > 500 I.U. per day of vitamin D supplements

• Primary diagnosis of asthma

• Uncompensated heart failure

• Heart attack in the previous 6 months

• Kidney disease (glomerular filtration rate < 45 mL/min/1.73m2)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Dietary Supplement:
• Vitamin D (cholecalciferol)
2000 I.U. daily for 6 weeks
• Placebo
Placebo (sugar pill) daily for 6 weeks

Locations

Country	Name	City	State
United States	Minneapolis VA Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Minneapolis Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Short Physical Performance Battery (SPPB) Score	SPPB measures lower extremity strength using 3 simple office-based tests to assess standing balance, gait speed, and chair stands. The composite SPPB score ranges from 0 (worst performance) to 12 (best performance). The minimal clinically important difference is not fully agreed upon, although a difference of 1.0 point has been used in many studies.	Baseline and 6 weeks	No
Secondary	Change in Blood Level of Vitamin D (25-hydroxyvitamin D)		Baseline and 6 weeks	Yes